Study of HSV immunotherapy (HSVTI) for healthy adults aged 18-40 and people with recurrent genital herpes aged 18-60

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What is this study about?

This study focuses on Herpes Simplex, specifically investigating a new targeted immunotherapy treatment called HSVTI. The research involves testing this treatment in two groups: healthy individuals aged 18-40 years and people aged 18-60 years who have recurrent genital herpes. The treatment is given as an intramuscular injection, and some participants will receive a placebo instead of the active treatment.

The purpose of this research is to evaluate how well people tolerate the treatment, assess its safety, measure the immune system response, and determine how effective it is at reducing episodes of genital herpes. The study will compare the new treatment to placebo to understand if it can help reduce the frequency of herpes outbreaks in people with recurring infections.

During the study, participants will receive multiple doses of either the study treatment or placebo. They will need to keep track of any symptoms in an electronic diary and attend follow-up visits. The researchers will monitor participants for any side effects at the injection site (such as redness or pain) and general body reactions (such as fever or tiredness). Blood samples will be collected to check how the immune system responds to the treatment.

1 Initial screening and eligibility

A blood test will be performed to check your HSV-2 (herpes simplex virus type 2) status and confirm you are HIV negative

Your medical history will be reviewed and a physical examination will be conducted

For Part I: You must be between 18-40 years old and HSV-2 negative

For Part II: You must be between 18-60 years old with confirmed HSV-2 and history of genital herpes for at least 1 year

2 First dose administration

You will receive an injection in your muscle (intramuscular injection)

Blood samples will be collected before the injection

You will need to monitor and record any injection site reactions (redness, pain, swelling) for 7 days

You will need to monitor and record any general symptoms (fever, fatigue, headache, muscle pain, joint pain) for 7 days

3 First follow-up period

Blood tests will be performed on day 8 and day 29 after the first injection

Any health issues will be monitored for 28 days after the injection

4 Second dose administration

A second muscle injection will be given

Similar monitoring of injection site reactions and general symptoms will be required for 7 days

5 Extended follow-up period

Blood tests will be performed according to your study part schedule

Part I participants: Tests on day 64, day 209, and day 394 after second dose

Part II participants: Tests on day 57 after second dose

Health monitoring will continue for 12 months after the last injection

Who Can Join the Study?

You must be willing and able to follow all study requirements, including completing electronic diaries and attending follow-up visits
You must provide written informed consent before any study procedures begin
You must be tested and confirmed negative for HIV (Human Immunodeficiency Virus)
For women who can become pregnant:
- Must use highly effective birth control for one month before starting the study
- Must have negative pregnancy tests at screening and before each treatment
- Must agree to continue birth control throughout the study period
For Part I participants:
- Must be healthy based on medical history and physical examination
- Must be between 18 and 40 years old
- Must test negative for HSV-2 (Herpes Simplex Virus Type 2)
For Part II participants:
- Must be between 18 and 60 years old
- Must test positive for HSV-2 through laboratory testing
- Must have been diagnosed with genital herpes for at least 1 year
- Must have had 3-9 outbreaks in the past 12 months
- Must not have significant health problems
For Part II shedding sub-group participants:
- Must complete at least 45 out of 56 required anogenital swabs during the baseline period

Who Cannot Join the Study?

People under 18 or over 65 years of age
History of immunodeficiency (weakened immune system) or immunosuppressive therapy
Individuals who received any vaccine within 30 days before the study
Pregnant or breastfeeding women
Current participation in other clinical trials
History of severe allergic reactions to vaccines
Active autoimmune disease (condition where immune system attacks healthy cells)
Chronic use of medications that affect immune system
History of malignancy (cancer) within the past 5 years
Severe chronic medical conditions that are not well controlled
Blood disorders or conditions affecting blood clotting
Active infection requiring treatment
History of drug or alcohol abuse within the past year
Mental conditions that could interfere with study compliance

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
CHU Saint Pierre	Brussels	Belgium
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Institute Of Tropical Medicine	Antwerp	Belgium
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH	Berlin	Germany
ICH Study Center GmbH & Co. KG	Hamburg	Germany
Kliiniliste Uuringute Keskus OÜ	Tartu	Estonia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
IKF Pneumologie GmbH & Co. KG	Frankfurt	Germany
Hospital Costa del Sol	Marbella	Spain
Dr. Scholten & Schneeweiß GbR	Cologne	Germany
Njkcyvwfxp Bkphnj Grp	Berlin	Germany
Ppmknhtk Dxoo Njsxahimgprauvga	Barcelona	Spain
Heweielm Vgfi dyzodtnq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	07.03.2022
Estonia	Not recruiting	07.03.2022
Germany	Not recruiting	07.03.2022
Spain	Not recruiting	07.03.2022

Trial locations

Investigated drugs:

Based on the provided trial information, there appears to be one main investigational therapy:

HSV-targeted immunotherapy (HSVTI) is a treatment designed to target the Herpes Simplex Virus (HSV). This therapy aims to help the immune system respond to HSV infections. It is being studied both in healthy people and in people who experience recurring genital herpes. The therapy is being tested to see if it is safe to use and if it can reduce the frequency of genital herpes outbreaks in people who have recurring episodes.

Herpes Simplex – A viral infection caused by the herpes simplex virus (HSV) that creates small, painful blisters on the skin or mucous membranes. The virus exists in two main types: HSV-1, which typically affects the oral region, and HSV-2, which usually affects the genital area. After initial infection, the virus remains dormant in nerve cells and can reactivate periodically, causing recurring outbreaks. During an outbreak, patients may experience tingling or burning sensations before blisters appear, followed by the formation of fluid-filled blisters that can break open and form sores. The virus spreads through direct contact with infected areas, particularly during active outbreaks.

Trial ID:

2024-510571-37-00

Protocol code:

215336

NCT ID:

NCT05298254

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of HSV immunotherapy (HSVTI) for healthy adults aged 18-40 and people with recurrent genital herpes aged 18-60

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?